The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for 9075.
Device ID | K760418 |
510k Number | K760418 |
Device Name: | 9075 |
Classification | Sealant, Pit And Fissure, And Conditioner |
Applicant | LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBC |
CFR Regulation Number | 872.3765 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-09 |
Decision Date | 1976-08-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
9075 72465123 1001829 Dead/Expired |
LEE PHARMACEUTICALS 1973-08-08 |